Clinical trials are some of the most expensive and difficult projects to perform. The average cost of pharmaceutical drug development is estimated to be between $80 million and $800 million depending on complexity and therapeutic area. Despite all of the advances in clinical trial technology, most clinical trial protocols are designed by committees and groups of highly paid people and take months to design. Once the protocol is approved by an appropriate regulatory body, it must be run at study centers all over the world. Each doctor and clinical research coordinator must then interpret the protocol to determine exactly what is required of them and their patients. They must then identify patients who might be appropriate for the study, obtain their consent, and then collect data on those patients over a period of months or years. The difficulty in performing such tasks and the inherent variability in these tasks being performed by hundreds or thousands of people in dozens of countries can lead to poor quality data, fraud, delays, and higher costs.
From a perspective of patients who have volunteered and/or were selected to be part of the study, the whole study process can be intimidating and confusing. It is not uncommon for the patients to be required to read and sign a 25 page legal document, thereby agreeing to certain terms and conditions of the study without actually understanding what they are signing. Once the patients are signed up for the study, they may be required to consume a pill at certain intervals and/or may be required to perform certain tasks at home such as answering questions and/or measuring their own body temperature, to name a few. If the patients fail to follow their instructions, the results from the study become inaccurate.
From a research coordinator's perspective, many hours are spent seeing the patients, asking the patients appropriate questions, performing certain procedures (e.g., drawing blood), dispending pills, instructing the patients. Such activities are then generally followed by processing paperwork. Results obtained from such tasks have to be logged and ultimately entered into a database system for further analysis. Each of these processes can be extremely time consuming.
On the other hand, a clinical research monitor oversees the research study project and can typically find that the research coordinators, doctors, patients, and nurses have not fully complied with the guidance specified in the protocol. Sometimes, lack of full compliance is intentional whereas other times it is unintentional. Non-compliance can result from data entry error, forgery, or lack of understanding, all of which can result in non-usable information for the research study, thereby costing more money to complete the study.
A sponsor spends a lot of money to perform such research studies and is always looking for ways to reduce their costs. One method of lowering such costs is to minimize redundancy and errors (or non-compliance) so that the studies can be performed in a shorter amount of time and without having to redo studies.